Revenue and Financial Performance - Revenue increased from RMB 51.89 million for the six months ended June 30, 2024, to RMB 100.05 million for the six months ended June 30, 2025, representing a year-on-year growth of 92.81%[15] - The total loss and comprehensive expenses for the period amounted to RMB 126.88 million, an increase of 10.92% compared to RMB 114.39 million in the previous year[18] - The adjusted net loss for the period was RMB 88.02 million, reflecting an increase of 11.64% from RMB 78.84 million in the prior year[18] - Gross profit increased from RMB 24.52 million for the six months ended June 30, 2024, to RMB 40.85 million for the six months ended June 30, 2025, an increase of 66.60%[44] - Other income surged from RMB 0.58 million for the six months ended June 30, 2024, to RMB 7.28 million for the six months ended June 30, 2025, a growth of 1,155.17%[45] - The company reported a loss before tax of RMB 125,214,000, which is a 9.3% increase from RMB 114,389,000 in the prior year[141] - The company reported a net loss attributable to owners of RMB 126,365,000 for the six months ended June 30, 2025, compared to a loss of RMB 114,328,000 in 2024, indicating a decline of 10.6%[173] Research and Development - The company has completed the research and development phase and is about to enter the registration clinical trial phase for its cognitive digital therapy, with data collection expected to be completed by early 2026[12] - A total of 649 patients were included in the randomized controlled trial for cognitive digital therapy in patients with hypertension and coronary heart disease, with data analysis and report writing completed, aiming for medical device registration submission in 2026[12] - The company has developed a depression treatment software, with clinical trials planned to start in 2026[12] - The ADHD treatment study showed significant improvement in core symptoms, with attention deficit scores improving from 23.3% to 34.6% in the combined treatment group[13] - The company plans to submit applications for medical device registration for multiple products in 2026, indicating a strong pipeline for future growth[12] - The Depression Cognitive Quantitative Assessment software is expected to complete clinical trials by Q3 2025, with commercialization anticipated in 2026[32] - The company is in preclinical development for a Depression Treatment software, projected to start clinical trials in Q1 2026[33] Product Development and Market Expansion - The company launched the BrainAu Onebox M1, a smart medical model machine, in 2025, representing a significant advancement in digital health transformation[16] - The core product, the Brain Function Information Management Platform, is the first regulatory-approved digital therapy product for cognitive impairment in China[22] - As of the report date, the core product has been included in the medical insurance reimbursement catalog of 30 provinces in China[22] - The product pipeline includes eight indications for four major types of cognitive impairment that have been commercialized, with three additional products approved in China and one in the EU[20] - The Basic Cognitive Ability Test software (BCAT) received regulatory approval in October 2022 and is set for commercialization in 2025[27] - The Cognitive Ability Screening Assessment software (SAS) was approved in December 2022 and is also scheduled for commercialization in 2025[28] - The Reading Disability Screening Assessment software (DSS) received approval in September 2023 and is expected to be commercialized in 2025[29] - The company is conducting clinical trials for a Reading Disability Rehabilitation Training software, which includes modules for perception and language training[30] - The company plans to expand its international footprint and establish a global presence by developing cognitive impairment assessment and treatment software for the US and EU markets[34] Operational Metrics - The number of hospitals purchasing the system increased from 186 in 2024 to 205 for the six months ended June 30, 2025[41] - Patient usage of the system rose from approximately 1,800,000 times in 2024 to 2,595,554 times for the six months ended June 30, 2025[41] - The number of cognitive centers increased from 107 in 2024 to 138 for the six months ended June 30, 2025, leading to increased operational costs[43] Expenses and Financial Management - Sales and distribution expenses rose from RMB 25.38 million for the six months ended June 30, 2024, to RMB 30.45 million for the six months ended June 30, 2025, an increase of 19.98%[48] - Administrative expenses increased from RMB 281.4 million for the six months ended June 30, 2024, to RMB 460.1 million for the six months ended June 30, 2025, representing a 63.5% increase[49] - R&D expenses rose from RMB 642.3 million for the six months ended June 30, 2024, to RMB 681.5 million for the six months ended June 30, 2025, an increase of 6.1%[50] - Financial costs increased from RMB 109.0 million for the six months ended June 30, 2024, to RMB 119.8 million for the six months ended June 30, 2025, a rise of 9.82%[53] Assets and Liabilities - Current assets as of June 30, 2025, amounted to RMB 6,701.4 million, with cash and cash equivalents at RMB 2,879.2 million, an increase of 2.88% from RMB 2,798.6 million as of June 30, 2024[56] - The current liabilities as of June 30, 2025, totaled RMB 2,753.3 million, including bank and other borrowings of RMB 1,431.0 million[56] - The gross profit margin decreased to 40.8% for the six months ended June 30, 2025, down from 47.3% for the same period in 2024[60] - The current ratio improved to 2.4 as of June 30, 2025, compared to 0.7 as of June 30, 2024[60] - Unpaid borrowings as of June 30, 2025, were approximately RMB 1,431.0 million, significantly up from RMB 161.3 million as of June 30, 2024[57] Shareholder Information and Corporate Governance - The company holds a total of 1,266,278,000 issued shares as of June 30, 2025[86] - The company’s major shareholders include Mr. Tan with a total holding of 401,701,000 shares, representing approximately 31.72% of the total shares[86] - The company has a significant concentration of ownership, with the top shareholders holding over 31.72% collectively[91] - The company is subject to the Securities and Futures Ordinance, which governs the disclosure of interests and shareholdings[91] - The audit committee reviewed the interim financial performance and confirmed compliance with relevant accounting standards and regulations[75] - The company has adhered to all applicable corporate governance code provisions since its listing date[130] Risks and Challenges - The company faces significant risks related to the successful completion of clinical development and regulatory approvals, which could adversely impact its business and financial outlook[81] - Regulatory requirements are becoming increasingly stringent, potentially hindering the development and launch of new products[84] - The company has a risk of product obsolescence if it fails to develop and launch competitive new products in a timely manner[81]
脑动极光(06681) - 2025 - 中期财报